Encephalopathy, HepaticdARICULtxNCT01597102
Cerebrovascular Autoregulation During and After Liver Transplantation
An observational study of Encephalopathy, Hepatic and Cerebrovascular Disorders, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The cerebrovascular autoregulation (AR) is impaired in patients with hepatic encephalopathy. Patients with the indication to liver transplantation mostly have mild to severe hepatic encephalopathy. Transplantation should recover the encephalopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Encephalopathy, Hepatic, Cerebrovascular Disorders, Liver Failure
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 8 Jan 2012to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with and stage liver failure and transplantation
Who may be able to join
- liver transplantation
- age > 18 years
Who cannot join
- sepsis
- preexisting cerebral diseases
- traumatic brain injury
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center
Mainz, 55131
Patrick Schramm, MD, 00496131176755, schrammp@uni-mainz.de
Patrick Schramm, MD
About this study
The cerebrovascular autoregulation (AR) is impaired in patients with hepatic encephalopathy. Patients with the indication to liver transplantation mostly have mild to severe hepatic encephalopathy. Transplantation should recover the encephalopathy. The aim of the study is to investigate the AR during liver transplantation, with the questions if the AR is impaired at the beginning of surgery and if there are changes in AR. For follow up the AR will be measured at the first days after transplantation at the ICU.
Read the detailed description
The cerebrovascular autoregulation (AR) will be measured using transcranial doppler and calculating the index of autoregulation Mx. This measurement is continuous with online calculation. So, the possible changes over the whole time of surgery can be detected. Furthermore, the measurement of AR at the ICU will be performed daily at the same time over a measurement period of 60 Minutes and the time course of AR after liver transplantation will be described.
- Being tested
- No interventions
- Keywords
- encephalopathy, hepatic, autoregulation, cerebrovascular, liver failure, liver transplantation
- Medical subject headings
- Hepatic Encephalopathy, Cerebrovascular Disorders, Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
Also called No intervention is planned in this study
No intervention is planned in this study
| Study group | Role | What they receive |
|---|---|---|
| Liver transplantation | Patients with liver failure and liver transplantation Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of cerebrovascular autoregulation during liver transplantation
Measuring cerebrovascular autoregulation during the whole liver transplantation and compare the index of AR at the beginning with index of AR Mx after reperfusion of the transplantated liver
Measured: During the surgery
Secondary outcomes (1)
Time course of cerebrovascular autoregulation after liver transplantation
Meaurement of cerebrovascular autoregulation daily for the first 4 days and calculating a time course
Measured: First 4 days after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study start8 Jan 2012
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Encephalopathy, HepaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Schramm, Johannes Gutenberg University Mainz
- Investigators
- Patrick Schramm, MD, Principal investigator, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597102
- Sponsor's protocol ID
- 837.041.10 III
- Acronym
- dARICULtx
- Status last verified
- Jun 2020
- First submitted
- 7 May 2012
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrovascular Autoregulation During and After Liver Transplantation
- ClinicalTrials.gov ID
- NCT01597102
- Acronym / sponsor ID
- dARICULtx / 837.041.10 III
- Keywords
- encephalopathy, hepatic, autoregulation, cerebrovascular, liver failure, liver transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 8 Jan 2012 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 11 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The cerebrovascular autoregulation (AR) is impaired in patients with hepatic encephalopathy. Patients with the indication to liver transplantation mostly have mild to severe hepatic encephalopathy. Transplantation should recover the encephalopathy. The aim of the study is to investigate the AR during liver transplantation, with the questions if the AR is impaired at the beginning of surgery and if there are changes in AR. For follow up the AR will be measured at the first days after transplantation at the ICU.
Detailed description
The cerebrovascular autoregulation (AR) will be measured using transcranial doppler and calculating the index of autoregulation Mx. This measurement is continuous with online calculation. So, the possible changes over the whole time of surgery can be detected. Furthermore, the measurement of AR at the ICU will be performed daily at the same time over a measurement period of 60 Minutes and the time course of AR after liver transplantation will be described.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplantation | – | Other: No interventionsPatients with liver failure and liver transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with and stage liver failure and transplantation
Key inclusion criteria (2 listed)
- liver transplantation
- age > 18 years
Key exclusion criteria (4 listed)
- sepsis
- preexisting cerebral diseases
- traumatic brain injury
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionsAlso: No intervention is planned in this studyNo intervention is planned in this study | Other | Liver transplantation |
Primary outcome
Changes of cerebrovascular autoregulation during liver transplantation
Time frame: During the surgery
Measuring cerebrovascular autoregulation during the whole liver transplantation and compare the index of AR at the beginning with index of AR Mx after reperfusion of the transplantated liver
1 secondary outcome
Time course of cerebrovascular autoregulation after liver transplantation
Time frame: First 4 days after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Schramm, MD principal investigator
Johannes Gutenberg University Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Encephalopathy, Hepatic and Cerebrovascular Disorders, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Schramm, MD (00496131176755, schrammp@uni-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of cerebrovascular autoregulation during liver transplantation (time frame: During the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.